A MEGA BOOK OF CLINICAL RESEARCH AND CLINICAL TRIALS New Drug Development Patent & Exclusivity Types of Animal Studies Pre-clinical toxicity Studies - LD50 Special Toxicity Studies - Carcinogenicity, Teratogenicity, Genotoxiciity, Reproductive toxicity Phases of Clinical Research ICH-GCP - Principles & Guidelines- IRB/IEC, Sponsor, Investigator, Site Clinical Trial Design - Types & Methods Pharmacodynamics Pharmacokinetics BA, BE ( Bioavailability, Bioequivalence) Quality - QMS, QA, QC Data Management - CDM Pharmacovigilance Clinical Research & Clinical Trials